GlobeNewswire Inc | Oct 16, 2020 08:30AM EDT

October 16, 2020

CAMBRIDGE, Mass., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc.(Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant bacterial infections and rare diseases, today announced that it will have 15 data presentations at theInfectious Disease Society of America(IDSA) IDWeek2020 taking place virtually fromOctober 21 - 25, 2020. Presentations will cover each of Speros three pipeline programs and include a late breaker oral presentation on the Phase 3 ADAPT-PO clinical trial that evaluated Speros oral antibiotic investigational candidate, tebipenem HBr, for the treatment of adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP). In September 2020, Spero announced positive top-line data from the trial demonstrating that oral tebipenem HBr was statistically non-inferior to intravenous (IV) ertapenem in the treatment of patients with cUTI and patients with AP. Poster presentations include a poster on the Phase 1 clinical trial of SPR720, an oral antimicrobial investigational agent in clinical development by Spero for the treatment ofnontuberculousmycobacterial (NTM)pulmonary disease. In December 2019, Spero announced positive data from this Phase 1 double-blind, placebo-controlled singleascending dose and multiple ascending doseclinicaltrialin healthy volunteers.

Presentations pertaining to tebipenem HBr andthe epidemiology and management of cUTI

Title:Oral Tebipenem Pivoxil Hydrobromide is Non-inferior to IV Ertapenem in Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP) Results from the Pivotal ADAPT-PO StudyPresenting Author Paul EckburgDate: Saturday, October 24, 2020Time: 10:00 11:15 AM EDT

Title:Characterization of Tebipenem Pivoxil Hydrobromide Pharmacokinetics-Pharmacodynamics (PK-PD) in a Neutropenic Murine Acute Pyelonephritis (AP) ModelPresenting Author Brian D. VanScoy Date:Wednesday, October 21, 2020Poster Session:PK/PD StudiesPoster Number: 1304

Title: Tebipenem: An Oral Carbapenem with Activity Against Multi-drug Resistant Urinary Tract Infection Isolates ofEscherichia coliCollected from US Medical Centers During 2019Presenting Author Ian A. Critchley Date:Wednesday, October 21, 2020Poster Session:UTIsPoster Number: 1695

Title: Epidemiology of Complicated Urinary Tract Infections (cUTIs) Presenting in Emergency Departments Across the United States (US)Presenting Author:Thomas Lodise Date:Wednesday, October 21, 2020Poster Session:UTIsPoster Number: 1673

Title: Hospital Admission Patterns in Adult Patients with Complicated Urinary Tract Infections (cUTIs): Identification of Potentially Avoidable Hospital Admissions Across United States (US) HospitalsPresenting Author:Thomas Lodise Date:Wednesday, October 21, 2020Poster Session:UTIsPoster Number: 1683

Title: Hospital Costs and Reimbursement in Patients with Resistant Enterobacteriaceae (ENT) Urinary Tract Infection (UTI) in the United States (US): A Multicenter AnalysisPresenting Author: Katherine SulhamDate:Wednesday, October 21, 2020Poster Session:UTIsPoster Number: 1684

Title: Eligibility and Outcomes of Conversion to Oral (PO) Therapy in Patients Hospitalized with Enterobacteriaceae (ENT) Urinary Tract Infection (UTI) in the United States (US): A Multicenter AnalysisPresenting Author: Katherine SulhamDate:Wednesday, October 21, 2020Poster Session:UTIsPoster Number: 1672

Title: Pre- and Post-Hospitalization Resource Utilization and Costs Associated with Urinary Tract Infection (UTI) in both Commercial and Medicare PopulationsPresenting Author: Katherine SulhamDate:Wednesday, October 21, 2020Poster Session:UTIsPoster Number: 1691

Title: Health Resource Utilization in Patients with Complicated Urinary Tract Infections (cUTI) and Antibiotic Resistance or Treatment Failure: A Retrospective Database AnalysisPresenting Author: Katherine SulhamDate:Wednesday, October 21, 2020Poster Session:UTIsPoster Number: 1682

Title: Clinical Characteristics and Demographics of Patients with Complicated Urinary Tract Infections (cUTI) and Antibiotic Resistance or Treatment Failure: A Retrospective Database AnalysisPresenting Author: Katherine SulhamDate: Wednesday, October 21, 2020Poster Session:UTIsPoster Number: 1670

Presentations pertaining to SPR720, Speros novel investigational oral antibacterial agent that targets enzymes essential for bacterial DNA replication:

Title: Phase 1 First-in-Human Single- and Multiple-Ascending Dose Trial Demonstrates Pharmacokinetics (PK) and Tolerability of SPR720, an Oral DNA GyrB Inhibitor for Mycobacterial InfectionsPresenting Author: Angela TalleyDate: Wednesday, October 21, 2020Poster Session:Novel AgentsPoster Number: 1288

Title: SPR720, A Novel Benzimidazole Gyrase Inhibitor, Demonstrates Potent Efficacy AgainstMycobacterium aviumATCC 700898 in a ChronicC3HeBFeJ Mouse Infection ModelPresenting Author: Nicole S. CotroneoDate:Wednesday, October 21, 2020Poster Session:Tuberculosis and other Mycobacterial InfectionsPoster Number: 1637

Title: Evaluating the Activity of SPR719, a Novel Aminobenzimidazole, against Nontuberculous MycobacteriaPresenting Author: Chris PillarDateWednesday, October 21, 2020Poster Session:Novel AgentsPoster Number: 1274

Title: Pharmacokinetics/pharmacodynamics of the Novel Gyrase Inhibitor SPR719/SPR720 and Clinical Dose Selection to Treat PulmonaryMycobacterium avium-complexDiseasePresenting Author: Tawanda GumboDate Wednesday, October 21, 2020Poster Session:Tuberculosis and other Mycobacterial InfectionsPoster Number: 1659

Presentations pertaining to SPR206, Speros next generation polymyxin investigational product candidate being developed to treat multi-drug resistant (MDR) Gram-negative infections in the hospital setting:

Title: Activity of SPR206, a Polymyxin B derivative, Compared to Colistin Alone and in Combination Against Multidrug-Resistant Pseudomonas aeruginosa StrainsPresenting Author: Jacinda C. Abdul-MutakabbirDate: Wednesday, October 21, 2020Poster Session:PK/PD studiesPoster Number: 1295

Abstracts are accessible via the IDWeek website. Poster presentations may be accessed through Spero Therapeutics website on the Key Publicationsand Presentations page under the Pipeline tab following their completion.

About Tebipenem HBrTebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is Speros novel investigational oral formulation of tebipenem pivoxil, a carbapenem antibiotic of the -lactam class marketed byMeiji Seika Pharma Co. Ltd. (Meiji) inJapanas Orapenemsince 2009 for pediatric infections limited to pneumonia, otitis media and sinusitis. Orapenem is not approved in the U.S. Carbapenems are an important subclass of antibiotics because they have been observed to be safe and effective in the treatment of drug-resistant Gram-negative bacterial infections.Tebipenem HBr is being developed for the treatment of cUTI, including AP. Spero expects to submit a New Drug Application submission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr in the second quarter of 2021. If approved, tebipenem HBr would be the first oral carbapenem to receive marketing approval intheUnited States. Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by theFDAfor the treatment of cUTI and AP.

About SPR720SPR720 represents a novel class of antibacterial agents in development that target enzymes essential for bacterial DNA replication. SPR720, an investigational new drug, was acquired from Vertex Pharmaceuticals and is currently under clinical development by Spero as an oral therapy for the treatment of non-tuberculousmycobacterial (NTM) pulmonary disease, a rare chronic orphan disease. Spero plans to initiate enrollment in its planned Phase 2a clinical trial evaluating SPR720 in patients with NTM pulmonary disease by year-end 2020.

Non-tuberculousmycobacteria are ubiquitous environmental pathogens that can cause progressive lung damage and respiratory failure, particularly in patients with compromised immune systems or underlying pulmonary disorders. Although rare, the incidence of NTM pulmonary disease is increasing worldwide. Treatment of NTM pulmonary disease requires prolonged therapy (continuing for approximately 12 to 24 months) with a combination of drugs approved for other infections and is frequently complicated by tolerability and/or toxicity issues. There are currently no oral antibiotics specifically approved for use to treat NTM pulmonary disease. Thus, if successfully developed and approved by the FDA, SPR720 has the potential to address an important unmet need as the first oral antibiotic approved for the treatment of this debilitating disease.

Under Speros collaboration with theBill and Melinda Gates Medical Research Institute, SPR720 will also be developed for the treatment ofMycobacterium tuberculosis(M. tb) infections in select economically disadvantaged countries. M. tb is a priority pathogen as defined by theWorld Health Organizationwith tuberculosis being one of the top ten causes of death worldwide and associated with both increasing resistance and sub-optimal current treatment approaches.

SPR720 has been granted QIDP designation by the FDA for the treatment of lung infections caused by NTM and lung infections caused byM. tband Orphan Drug Designation by the FDA for the treatment of NTM infection.

About SPR206SPR206 is an investigational agent designed to be IV administered and act directly on Gram-negative bacterial infections through the molecules interactions with the bacterial outer membrane. SPR206 has demonstratedpotent broad-spectrum activityagainst Gram-negative bacteria, including organisms identified by theCenters for Disease Control and Prevention and theWorld Health Organization as urgent and serious threats to human health. Spero expects to initiate a Phase 1 bronchoalveolar lavage clinical trial assessing the penetration of SPR206 into the pulmonary compartment inthe first half of 2021 and initiate a renal impairment study of SPR206 in 2021. SPR206 has been granted QIDP designation by the FDAfor the treatment of cUTI and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

Tebipenem HBr Research SupportThis project has been funded in part with Federal funds from theDepartment of Health and Human Services;Office of the Assistant Secretary for Preparedness and Response;Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201800015C.

SPR720 Research SupportResearch reported in this publication was partially supported by theNational Institute of AllergyandInfectious Diseases, part of the National Institutesof Health, under Award Number R44AI131749. The content is solely the responsibility of the authors and does not necessarily represent the official views of theNational Institutes of Health.

SPR206 Research SupportClinical research for the SPR206 program is funded by The U.S. Army Medical Research Acquisition Activity,839 Chandler Street,Fort Detrick MD217025014, which is the awarding and administering acquisition office. This work was supported by theOffice of the Assistant Secretary of Defense for Health Affairs, through the Joint Warfighter Medical Research Program under Award No. W81XWH-19-1-0295. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by theDepartment of Defense.

Non-clinical research for the SPR206 program is funded in part with Federal funds from theNational Institute of Allergy and Infectious Diseases,National Institutes of Health,Department ofHealth and Human Services, under Contract No. HHSN272201500014C.

Non-clinical research for the SPR206 program was funded in part by The U.S. Army Medical Research Acquisition Activity,820 Chandler Street,Fort Detrick MD21702-5014, whichis the awarding and administering acquisition office. This work was supported in part by theOffice of the Assistant Secretary of Defense for Health Affairs, through the Peer Reviewed Medical Research Program under Award No. W81XWH-16-2-0019. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by theDepartment of Defense.

AboutSpero TherapeuticsSpero Therapeutics, Inc.is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections and rare diseases.

Speros lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is being developed as the first oral carbapenem antibiotic for use in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). InSeptember 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in cUTI and AP.

Spero is also advancing SPR720, its novel oral therapy product candidate being developed for the treatment of rare, orphan pulmonary disease caused by non-tuberculous mycobacterial (NTM) infections.

Spero also has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform that is being developed to treat MDR Gram-negative infections in the hospital setting.

For more information, visit https://sperotherapeutics.com.

Forward-Looking StatementsThis press release may contain forward-looking statements. These statements include, but are not limited to, statements about the initiation, timing and submission to the FDA of a NDA for tebipenem HBr and the potential approval of tebipenem HBr by the FDA; future commercialization, the potential number of patients who could be treated by tebipenem HBr and market demand for tebipenem HBr generally; expected broad access across payer channels for tebipenem HBr; the expected pricing of tebipenem HBr and the anticipated shift from IV to oral administration; the design, initiation, timing, progress and results of Speros preclinical studies and clinical trials and its research and development programs, including the commencement of Speros planned Phase 2a clinical trial of SPR720 and the commencement of Speros planned Phase 1 bronchoalveolar lavage (BAL) clinical trial assessing the penetration of SPR206 into the pulmonary compartment and its renal impairment study of SPR206; and managements assessment of the results of such preclinical studies and clinical trials. In some cases, forward-looking statements can be identified by terms such as may, will, should, expect, plan, aim, anticipate, could, intent, target, project, contemplate, believe, estimate, predict, potential or continue or the negative of these terms or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including Speros ability to timely complete related Phase 1 trials for its planned NDA submission for tebipenem HBr, taking into account the possible effects of the COVID-19 pandemic; Speros need for additional funding; the lengthy, expensive, and uncertain process of clinical drug development; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; Speros reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; the ability to develop and commercialize Speros product candidates, if approved; the potential impact of the COVID-19 pandemic; Speros ability to retain key personnel and to manage its growth; and other factors discussed in the Risk Factors set forth in filings that Spero periodically makes with theU.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Speros views as of the date of this press release. Spero anticipates that subsequent events and developments will cause its views to change. However, while Spero may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Speros views as of any date subsequent to the date of this press release.

Spero Investor and Media Contact:Sharon KlahreSenior Director, Investor Relations857-242-1547IR@sperotherapeutics.com